Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)

Acute Respiratory Failure Clinical Trial

— WEANLUS-BR  

Official title:

Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01966861
• Other study ID #: IDOR-03-2013
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: October 15, 2013
• Last updated: March 1, 2018
• Start date: March 2016
• Est. completion date: May 2019

Study information

• Verified date: March 2018
• Source: D'Or Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study aims to evaluate the impact of a weaning strategy based on identification of early signs of respiratory distress by lung ultrasound and the consequent implementation of a "clinical optimization" protocol as compared to usual care.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mechanically ventilated >48h

Exclusion Criteria:

• Moderate/Severe COPD

• Spinal cord lesion

• Neuromuscular disease (previous)

• Lung fibrosis

• Tracheostomy

• Heart failure (EF<50%)

• Lung/pleural cancer

• inadequate "window"for LUS

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Other:
• weaning guided by LUS (lung ultrasound)
Predictive early signs of respiratory distress are assessed by lung ultrasound (LUS score >14) and if present will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis, antibiotics when required [CPIS>6], hemglobin>8g/dl triggers transfusion)

Locations

Country	Name	City	State
Brazil	D'OR Institute for Research and Education	Rio de Janeiro

Sponsors (4)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Hospital Israelita Albert Einstein, Hospital Sirio-Libanes, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory distress requiring re-intubation or non-invasive ventilation		48hours
Secondary	28-day mortality		28 days
Secondary	Hospital Mortality		Hospital death/discharge (up to 60 days)
Secondary	Adverse events	Renal dysfunction, complications of thoracocentesis, hydro-electrolite changes, hypotension	48h